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Purcise™ SLE 0.2 μm PES Sterilizing-grade Standard Filter Cartridge

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Part No. ASLES022SQP
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*Not for medical use

Cobetter Filter cartridges are available in a complete range of lengths from 2.5" to 40", providing flexible scale-up solutions from laboratory development and pilot studies to full-scale manufacturing. Designed with excellent compatibility and scalability, the cartridge filters support seamless process transfer and linear scale-up while maintaining consistent filtration performance across different stages.

Purcise™ SLE features sterilizing-grade filters with double-layer hydrophilic Polyethersulfone (PES) membrane, offering low protein adsorption and excellent filtration efficiency, making them a preferred solution for final sterile filtration in biopharmaceutical manufacturing processes.

Features

  • Double Layer Hydrophilic Polyethersulfone (PES) Membrane: 0.45 μm pre-filter + 0.2 μm final filter membrane, ensuring high throughput and flow rate. Exceptional chemical compatibility. Low adsorption and low leachable.
  • Sterilizing -grade Filter: Bacterial Retention validated according to ASTM F838, each filter is integrity tested prior to release.
  • Linear Scale Up: Available in syringe filter for filterability study, small-scale capsule filter for process development, and large-scale capusle filter and filter cartridge for commercial GMP manufacturing.

Applications

  • Sterile filtration of terminal products
  • Sterile filtration of biological products
  • Blood and serum products
  • Sterile filtration of vaccine products
  • Pre-column/ultra-filtration protection
  • Filtration of intermediate products/stock solutions

Quality Standards

  • ISO 9001: 2015 Quality Management System
  • Manufactured for use in conformance with cGMP
  • Each product is integrity tested prior to release
  • Unique serial number for full traceability
  • COA/COQ provided with shipment
  • Validation documents are available upon request
Physical Properties Filter Format Cartridge Filter
Scale Production Scale
Filtration Area 0.14 m², 0.28 m², 0.55 m²,1.1 m², 1.65 m², 2.2 m²
Pore Size 0.2 μm (final-filter)
Pre-filter 0.45 μm
Bubble Point (per 0.55 m²) ≥0.39 MPa at 20 °C, water wetted, air
Materials Membrane Material Polyethersulfone (PES)
Support Fleece Polypropylene (PP)
Housing Polypropylene (PP)
O-ring / Seal Silicone / EPDM / Fluoroelastomer
Operating Conditions Max. Differential Pressure (Forward) 0.69 MPa at 25 °C
0.4 MPa at 60 °C
0.24 MPa at 80 °C
Max. Differential Pressure (Reverse) 0.3 MPa at 25 °C
0.1 MPa at 80 °C
Regulatory Compliance Compliance USP <788> Particulate Matter
USP <87> Cytotoxicity
USP <88> Biological Reactivity
FDA Indirect Food Additives, 21 CFR 177-182
ADCF Materials
Bacterial Retention 10⁷ cfu/cm² Brevundimonas diminuta (ATCC 19146) according to ASTM F838
Bacterial Endotoxin Endotoxin Limit of WFI System<0.25 EU/mL with the Limulus Amebocyte Lysate (LAL), USP <85>
Non-Fiber Releasing The products meet the criteria as defined in 21 CFR 210.3(b)(6)
Sterility Delivery Condition Non-sterile
Sterilization Method Can be SIP for 30 min at 135 °C 50 cycles (<30kPa)

Can be autoclaved 50 cycles for 30 min at 130 °C
Package Pack Size Pack of 1
Packaging Individually packed in a double PE bag

 
What is the difference between nominal-rated membranes and absolute-rated membranes?

Nominal-rated membranes and absolute-rated membranes differ in manufacturing processes and materials. PP and GF membranes are nominal-rated and are typically used for clarification to remove visible particles, but they cannot be subjected to integrity testing. PES, PVDF, PTFE, and nylon are mostly absolute-rated membranes. They are generally used for bioburden reduction or sterile filtration of liquid and gas, with established standards for integrity testing.

How to define sterilizing-grade filters?

Sterilizing-grade filters are required to produce a sterile filtrate in a standard microbial challenge test (1 × 10⁷ CFU/cm² of Brevundimonas diminuta) and to establish a clear correlation with a practicable non-destructive physical integrity test. Such filters are commonly described as having a nominal pore size of 0.2/0.22 µm.

Can a 0.45 µm filter achieve complete sterilization?

A 0.45 µm absolute-rated filter can remove larger bacteria and microorganisms, with a removal efficiency of greater than 90%, and therefore can only be classified as a bioburden-reducing (or bacteria-reducing) filter. To achieve complete bacterial removal, a 0.22 µm absolute-rated filter is recommended.

What materials and filter formats are available for Cobetter sterilizing-grade filters?

Cobetter offers sterilizing-grade filters made from PES, PVDF, PTFE, and other membranes. The available formats include syringe filters, capsule filters in various sizes, and cartridge filters.

What are the advantages and benefits of Cobetter sterilizing-grade filters?

1. Gradient pore structure design, which enhances filtration flux and dirt-holding capacity.
2. Low extractables and leachables, with low protein binding.
3. Available in single-layer or composite membrane configurations.
4. Comprehensive product range and multiple connection options, suitable for a wide variety of application scenarios.